Somatostatin analogue composition and use in treating breast cancer

- Novartis Corporation

The invention provides a pharmaceutical composition containing a somatostatin analogue, and its use in the treatment of breast cancer. The pharmaceutical composition preferably contains lactic acid in addition to the somatostatin analogue and is better tolerated when administered by injection.

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1. A pharmaceutical composition consisting of octreotide acetate and 88% lactic acid, in the ratio of 1 part of octreotide to 5 parts of lactic acid, up to 1 part of octreotide to 60 parts of lactic acid, and with sodium hydrogen-carbonate to pH 4 to 4.5, and mannitol in isotonic sterile water, for parenteral administration.

2. The pharmaceutical composition of claim 1, in which the ratio of octreotide acetate to lactic acid is 1 to 5 up to 1 to 40.

3. The pharmaceutical composition of claim 1, in which the octreotide acetate is present at from 0.05 to 1 mg per ml, and the lactic acid is present at 3 mg per ml.

4. The pharmaceutical composition of claim 1, in which the pH is 4.2.

5. A method of treating breast cancer in a subject which comprises administering a therapeutically effective amount of the composition of claim 1 to a subject in need of such treatment.

6. A method of claim 5 in which the composition in co-administered with a dopamine agonist.

Referenced Cited
U.S. Patent Documents
5384309 January 24, 1995 Barker et al.
Foreign Patent Documents
0203031 November 1986 EPX
0215171 March 1987 EPX
Patent History
Patent number: 5753618
Type: Grant
Filed: Jun 6, 1995
Date of Patent: May 19, 1998
Assignee: Novartis Corporation (Summit, NJ)
Inventors: Thomas Cavanak (Biel-Benken), Alan Harris (Basel)
Primary Examiner: Ponnathapura Achutamurthy
Assistant Examiner: T. D. Wessendorf
Attorney: Hesna J. Pfeiffer
Application Number: 8/471,706